Olympus America Inc. Evergreen Regulatory Affairs Engineer - External in San Jose, California
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The Regulatory Affairs Engineer will be responsible for assisting in the investigation of complaints and reportable events at several levels. The incumbent will work closely with Original Equipment Manufacturers (OEMs) and local departments to promote quality improvements to both products and quality system processes by initiating and driving corrective and preventive actions. He/She will offer solutions concerning quality discrepancies and process improvements based on data collection, trend analysis and reporting activities. The incumbent will participate in the Internal Audit team to insure compliance with the quality management system and associated regulations throughout the Medical Systems Group (MSG). He/She will help ensure the uniform and timely closure of product complaints by serving reviewing and closing product complaint files in accordance with established procedures. EOE M/F/D/V
Primary Hiring Locations: San Jose, CA
Assist RA Analysts by conducting timely complaint and MDR investigations.
Participate in telephone interviews with customers and field personnel, and by performing on-site visits.
Work with team members and microbiology staff relative to CDS-related complaints.
Provide technical support to technicians, complaint administration staff and production shop floor staff relative to technical investigations.
Participate in monthly complaint review and CAPA meetings.
Support Quality Management System (QMS) by performing periodic product, process, internal and vendor audits and facilitate preventative and corrective action activities (CAPA).
Work directly with the OEM to facilitate corrective and preventive action activities (CAPA) related to quality problems identified through complaint investigations and/or other sources of quality data.
Participate in process validation and New Product / Repair Introduction activities as needed.
*Serve as a technical trainer to RA Team members.
Develop and run reports in DataSweep, Adwatch, or other database systems for the purpose of trend monitoring and/or complaint investigation.
Perform other related duties as assigned.
Olympus America, Inc. with headquarters in Center Valley, PA is a precision technology leader, creating innovative opto-digital solutions in health care and life science products throughout North America. Olympus works collaboratively with its customers and its affiliates worldwide to leverage R&D investment in precision technology and manufacturing processes across diverse business lines. These include: gastrointestinal endoscopes, accessories, and minimally invasive surgical products; advanced clinical and research microscopes. Olympus America Inc at http://www.olympusamerica.com/
(ONLY QUALIFIED CANDIDATES WILL BE CONSIDERED)
Bachelor's degree in a technical discipline (e.g. EE, ME, BME, IE, Microbiology, Chemistry, Quality Assurance) or equivalent knowledge is required.
Minimum of 2 years experience dealing with regulatory or quality assurance issues in the medical device or pharmaceuticals industries is required. Previous experience must include complaint-handling activities.
Olympus America Inc at http://www.olympusamerica.com/
Evergreen Requisition - Regulatory Affairs Engineer
Reg Affairs/Quality Assurance
California, San Jose
San Jose OCA
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